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Showing 8001–8020 of 15081 results

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Bupivacaine HCl (Pharmedium Services) – Incorrect Labeling (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

Ropivacaine HCl 0.2% ON-Q Pump (Pharmedium) – Labeling Issue (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

Salicylic Acid Cream (Perrigo) – Impurity Specifications (2017)

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

Class IIILow

FDAFeb 13, 2017Nationwide• L. Perrigo Company

Salicylic Acid Shampoo (Perrigo) – Impurity Specifications (2017)

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

FDAFeb 13, 2017Nationwide• L. Perrigo Company

PreviDent 5000 (Colgate) – Label Mixup (2017)

Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.

FDAFeb 13, 2017Nationwide• Colgate Palmolive Co

Theravits 100 (World Organic) - Fish Liver Oil Disclosure (2017)

World Organic Corporation dba Licata Enterprise is recalling multiple vitamins because it contains fish liver oil that is declared on the product label; however, the label also states "Contains NO...common allergens." The product also contains the following dietary ingredients that are missing from the label: molybdenum, pancreatin, diastase, papain, ox bile, vanadium, silicon, boron and bromelain.

Class IIModerate

FDAFeb 13, 2017CA, ID, OH +7 more• World Organic Corp.

Pharmanex Cortitrol (Nu Skin) - Undeclared Soy (2017)

Undeclared Allergen

Nu Skin announces a voluntary field action for Pharmanex Cortitrol due to undeclared allergen; soy.

Class IIModerate

FDAFeb 13, 2017Nationwide• Nu Skin Enterprises Inc.

Clear 2 Topical (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Lactic Acid Solution (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

MALEK'S MAGIC (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Glycolic Acid 15% Lotion (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Tri-Bleaching Cream HQ (Synergy Rx) – Manufacturing Defects (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

HCG and HCG with Resveratrol (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Retinoic Acid Solution (Synergy Rx) – Sterility Concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

FIRM AND FADE CREAM (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Metronidazole Injection (Hospira) – leaking bag (2017)

Lack of Sterility Assurance: customer report of leaking bag

Class IIModerate

FDAFeb 10, 2017Nationwide• Hospira Inc., A Pfizer Company

CLARIFYING CREAM (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

TRI-BLEACHING CREAM (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

Acne Solution (Synergy Rx) – Sterility Concern (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

HCG Powder (Synergy Rx) – sterility concerns (2017)

Lack of Assurance of Sterility: There are also CGMP Deviations.

Class IIModerate

FDAFeb 10, 2017Nationwide• Synergy Rx

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